MK0431 Safety and Efficacy in Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Pioglitazone Therapy

Study start date: June 1, 2004

Inclusion Criteria: * Patient has type 2 diabetes mellitus (T2DM) * Patient is 18 years of age (or older) * Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and poststudy follow-up period Exclusion Criteria: * Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis * Patient required insulin within the prior 8 weeks * Patient is on a weight loss program and is not in the maintenance phase * Patient started on a weight loss medication (e.g., orlistat or sibutramine) within the prior 8 weeks * Patient is on or likely to require treatment with treatment with immunosuppressive agents (e.g., cyclosporin, methotrexate) * Patient has cirrhosis, active liver disease (other than fatty liver) or symptomatic gallbladder disease * Patient has chronic myopathy, or a progressive neurological or neuromuscular disorder (e.g., multiple sclerosis or polymyositis) * Patient has any of the following disorders within the past 6 months: Acute coronary syndrome (e.g., MI or unstable angina), Coronary artery intervention, Stroke or transient ischemic neurological disorder. * Patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months * Patient has severe peripheral vascular disease * Patient has congestive heart failure * Patient is HIV positive * Patient has a clinically important hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia) * Patient has a history of neoplastic disease * Patient has a history of alcohol or drug abuse within the past 3 years * Patient has viral hepatitis (hepatitis B or C)